Qualification Engineer / Pharma Equipment Engineer (m/f/d)

About the job

Become part of our team and shape international biopharma projects with us

CB Consultancy AG has been an established engineering and consulting partner for demanding projects in the biopharmaceutical industry since 2012. From our location in Winterthur, we support our clients in international projects – from the initial project idea through engineering and realisation to successful commissioning and handover.

What sets us apart: We combine profound process understanding with technical engineering and many years of experience in the GMP-regulated environment. We not only work on concepts and plans but also accompany our projects through to realisation and take responsibility where engineering becomes concrete.

With us, you can expect varied international projects, challenging technical tasks, and the opportunity to actively take on responsibility. Short decision-making paths, direct collaboration within our team and with our clients, as well as a high degree of personal responsibility, characterise our way of working.

To strengthen our team, we are looking for a committed individual who wants to realise a demanding international biopharma project together with us.

YOUR TASKS

For the construction of a new biopharmaceutical production facility in South Africa, we are seeking a technically skilled person with solid experience in the realisation, commissioning, and qualification of production equipment.

The focus of your work is the technical acceptance and qualification of USP and DSP process equipment for vaccine production. You will accompany the equipment from suppliers in China to installation and commissioning at the production site in South Africa (Cape Town).

Your tasks include in particular:

• Preparation, accompaniment, and documentation of Factory Acceptance Tests (FAT) at equipment suppliers in China as well as Site Acceptance Tests (SAT) at the client in South Africa
• Technical review and qualification of process equipment for biopharmaceutical production such as: media and buffer preparation, biosafety isolators, bioreactors (BSL2) for bacterial cultivation and inactivation, quarantine, purification and MVB tanks, system for final formulation before filling
• Review of test plans and protocols for FAT, SAT, IQ and OQ
• Review of technical documentation as well as structured recording and follow-up of deviations
• Coordination and close collaboration with equipment suppliers, engineering, quality assurance, and the local project team
• Active support during commissioning, testing, and qualification of the equipment on site
• Regular international travel to suppliers in China and to the project site in South Africa, sometimes for longer assignments

The planned project assignment extends from January 2027 to October 2027

YOUR PROFILE

You have a good technical understanding, know the requirements of biopharmaceutical production, and feel comfortable both at equipment suppliers and directly on site or in the production environment.

Ideally, you bring the following:

• Technical education, for example in process engineering, biotechnology
• Several years of practical experience in the biopharma industry
• Profound knowledge of biopharmaceutical process equipment and production facilities
• Experience with FAT and SAT as well as commissioning and qualification
• Good knowledge of GMP requirements as well as documentation and traceability requirements
• Very good English skills in spoken and written form for daily collaboration in an international project environment
• Willingness to undertake regular international travel and longer assignments on site
• Independent, structured, and solution-oriented working style
• Strong communication skills and enjoyment of working with international teams

CONDITIONS

WORK LOCATION - Winterthur as well as international project assignments, especially in China and South Africa

WORKING TIME - 100%

TYPE OF EMPLOYMENT - Depending on profile and personal situation, different forms of cooperation are possible – project-based employment, freelance activity, permanent employment

START OF WORK - immediately or by arrangement

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